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C.R. Bard, Inc. recalls BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and contr
Recalled April 20, 2016 · FDA recall Z-1395-2016 · C.R. Bard
Hazard
Complaints were received of restricted/inaccurate flow rate. · FDA Class II
Units
21,412 units
Sold at
Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.
Description
Complaints were received of restricted/inaccurate flow rate.
Product
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →